A recent article by Marilynn Marchione, released by the Associated Press, explores the risks of drugs on the market and questions when a drug is too risky to be on the market after drug safety questions arose again this week about the Diabetes drug Avandia.
The author cites examples to show that at times the FDA’s actions may seem inconsistent or even confusing. She mentions two drugs tied to heart risk, one which was removed from the market and another wasn’t. She also mentions a drug that was pulled off, then put back on the market. She explains that the Food and Drug Administration has vague guidelines for deciding what to do in these cases.
Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, explains "each drug has its own complex story," so comparisons to previous decisions can't be made, adding that the agency needs better criteria regarding drug safety.
The author explains that the FDA can order a drug off the market, but this order can be challenged in court and usually a company voluntarily withdraws the medicine at the FDA's request. She explains that some of the factors considered in assessing a drug’s safety are:
How serious is the illness?
How serious are the potentially adverse effects?
How frequent are the risks?
She continues by giving many examples of different decisions by the FDA but ultimately discusses Avandia and its fate.
She explains that there is a potentially safer alternative to Avandia, Actos, not all studies have tied Avandia to heart risks and deaths, and more data need be collected. The drug initially won approval in 1999 because it lowered blood sugar, which is a less clear benefit than other results. She also mentions that some experts are not happy that even though Avandia has been approved because according to one expert “we still don’t know if it produces the benefits we really want.”
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